Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT04083456
Eligibility Criteria:
Inclusion Criteria:
* Within the age range of 50-85 years
* Confirmed diagnosis of Type II Diabetes Mellitus (DM) and/or Peripheral Artery Disease (PAD)
* Transtibial, knee disarticulation, or transfemoral lower-limb amputation (LLA) (or re-amputation) within the past 12 months
* Participant goal of household walking or better using a prosthesis
Exclusion Criteria:
* Trauma or cancer-related etiology of the LLA
* Decisionally challenged individuals (MMSE score below 24)
* Prisoners
* Active cancer treatment
* Recent stroke (within 2 years)
* Clinical discretion of principal investigator to exclude patients who are determined to be unsafe and/or inappropriate to participate in the described intervention.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT04083456
Study Brief:
Protocol Section:
NCT04083456